AED having CPR period with pause for ECG acquisition

ABSTRACT

A method for using a defibrillator is described which executes a resuscitation protocol having a CPR pause period. The defibrillator prompts a rescuer to perform CPR during a CPR pause period. The CPR pause period may be interrupted for the acquisition of ECG signal data which is not contaminated by chest compression artifacts. Following the acquisition of ECG signal data, the CPR period resumes and continues for its full period. The ECG signal data acquired during the interruption of the CPR period is analyzed and, if a shockable rhythm is identified, a shock sequence is initiated immediately upon conclusion of the CPR period.

This is a continuation of U.S. Ser. No. 12/517,223, filed Jun. 2, 2009,which is a U.S. National Phase Application of International ApplicationNo. PCT/IB2007/054878, filed on Nov. 30, 2007 and claims the benefit ofU.S. Provisional No. 60/869,014, filed on Dec. 7, 2006.

The invention generally relates to medical equipment, and moreparticularly, to automatic external defibrillators providing combineddefibrillation and CPR pause modes of operation.

Defibrillators deliver a high-amplitude current impulse to the heart inorder to restore normal cardiac rhythm and contractile function inpatients who are experiencing arrhythmia, such as ventricularfibrillation (“VF”) or ventricular tachycardia (“VT”) that is notaccompanied by a palpable pulse. There are many classes ofdefibrillators, including manual defibrillators and automatic externaldefibrillators (“AEDs”). AEDs differ from manual defibrillators in thatAEDs can automatically analyze patient electrocardiogram (“ECG”) rhythmto determine if defibrillation is necessary. In most AED designs, theuser is prompted to press a shock button to deliver the defibrillationshock to the patient.

AEDs are typically configured to provide a user with visual or audioprompts to carry out a medical protocol that includes both delivery ofelectrotherapy as well as performing cardio-pulmonary resuscitation(“CPR”). Research has shown that the application of early and extensiveCPR can increase the chances of survival, particularly for patients whohave been in VF for many minutes prior to treatment. Accordingly,resuscitation protocols have been developed to both detect and treat VFas well as guide the rescuer in the administration of CPR. For example,PCT patent application number IB2006/051897 (Snyder et al.) describes anAED with a protocol that selects either a shock-first or a CPR-firstprotocol based upon ROSC scoring. U.S. Pat. No. 6,553,257 (Snyder etal.) and US patent application publication no. 2006/0116724 (Snyder)describe an AED which is prepared for shock delivery prior to the end ofthe CPR pause period so that a shock can be delivered promptly followingCPR if advised. Several patents such as U.S. Pat. No. 7,039,457 (Younget al.) and US patent application publication no. 2006/0149157 (Weil etal.) propose to acquire and analyze the patient's ECG while CPR is beingadministered, and to discern the heart waveform from the artifactscreated by the CPR compressions by the irregularity and high amplitudeof the artifacts. This is said to be an improvement over prior artapproaches in which CPR is interrupted for a “quiet” period of 12 to 25seconds while the defibrillator acquires and analyzes the ECG waveformwithout interruption from artifacts, then delivers a shock if advised.However the accurate detection of a VF ECG waveform neverthelesspresents a serious challenge for most artifact removal techniques.Consequently the acquired ECG data should be checked for artifactsbefore it is accepted for analysis. Discovery of artifact contaminationcan result in rejection of all of the data of the analysis window,requiring another attempt at ECG acquisition which further delaystreatment. Accordingly it is desirable to maximize the time during CPRpause periods for the delivery of chest compressions and ventilationwhile at the same time promptly reliably delivering a shock if advised.

In accordance with the principles of the present invention, adefibrillator monitors for breaks in CPR administration, preferably bysensing CPR activity from small signal chest impedance measurement. If abreak is detected, ECG signal data is acquired and analyzed. If no breakin CPR occurs, a pause in CPR administration is prompted and ECG signaldata is acquired and analyzed during the prompted break. The CPR periodis resumed and completed, at which time a shock is delivered if advised.In accordance with a further aspect of the present invention, the ECGanalysis is used in a V-rhythm assessment of the success ofresuscitation and, if success is indicated and a shock is advised, theCPR period is terminated immediately for shock delivery.

In the drawings:

FIG. 1 is an illustration of a defibrillator being applied to a patientsuffering from cardiac arrest.

FIG. 2 is an illustration of a defibrillator and electrodes in which acombined monitor and CPR pause mode of operation according to anembodiment of the present invention can be implemented.

FIG. 3 is a is a simplified block diagram of the defibrillator of FIG.2.

FIG. 4 is a flow diagram of a defibrillator operating protocolincorporating a CPR pause mode of operation.

FIG. 5 is a flow diagram of a defibrillator operating protocolincorporating an interruptible CPR mode of operation in accordance withthe principles of the present invention.

Referring first to FIG. 1, an AED 10 is illustrated being applied by auser 12 to resuscitate a patient 14 suffering from cardiac arrest. Incardiac arrest, the patient is stricken with a life threateninginterruption to the normal heart rhythm, typically in the form of VF orVT that is not accompanied by a palpable pulse (i.e., shockable VT). InVF, the normal rhythmic ventricular contractions are replaced by rapid,irregular twitching that results in ineffective and severely reducedpumping by the heart. If normal rhythm is not restored within a timeframe commonly understood to be approximately 8 to 10 minutes, thepatient 14 will die. Conversely, the quicker defibrillation can beapplied after the onset of VF, the better the chances that the patient14 will survive the event.

A pair of electrodes 16 are applied across the chest of the patient 14by the user 12 in order to acquire an ECG signal from the patient'sheart. The AED 10 then analyzes the ECG signal for signs of arrhythmia.If VF is detected, the AED 10 signals the user 12 that a shock isadvised. After VF or other shockable rhythm has been identified by theAED, the user 12 presses a shock button on the AED 10 to deliver adefibrillation pulse to resuscitate the patient 14.

FIG. 2 illustrates a defibrillator according to an embodiment of thepresent invention. For purposes of the discussion that follows, thedefibrillator is configured as an AED 410, and is designed for smallphysical size, light weight, and relatively simple user interfacecapable of being operated by personnel without high training levels orwho otherwise would use the AED 410 only infrequently. A clinical orhospital defibrillator used by medical professionals, on the other hand,tends to be larger, heavier, and have a more complex user interfacecapable of supporting a larger number of manual monitoring and analysisfunctions. Although the present embodiment of the invention is describedwith respect to application in an AED, other embodiments includeapplication in different types of defibrillators, for example, manualdefibrillators, and paramedic or clinical defibrillators.

A pair of electrodes 416 is connected to a connector 426 for insertioninto a socket 428 of the AED 410. Located on a top surface of the AED410 is an on-off switch 418 that activates the AED 410 and begins theprocess of the prompting the user to apply the electrodes 416 to thepatient. A status indicator 420 provides a continual visual indicationof the defibrillator status and the available battery charge. A display422 preferably provides for display of text such as user prompts andgraphics such as ECG waveforms. A shock button 424 provides for deliveryof the shock to the patient if ECG analysis indicates that a shockablerhythm is present. Administration of defibrillation shocks is done byprompting the user to manually press the shock button 424.

FIG. 3 is a simplified block diagram of the AED 410 according to anembodiment of the present invention. An ECG front end 502 is connectedto the pair of electrodes 416 that are connected across the chest of thepatient 14. The ECG front end 502 operates to amplify, buffer, filterand digitize an electrical ECG signal generated by the patient's heartto produce a stream of digitized ECG samples. The digitized ECG samplesare provided to a controller 506 that performs an analysis to detect VF,shockable VT or other shockable rhythm. If a shockable rhythm isdetected, the controller 506 sends a signal to HV delivery circuit 508to charge-up in preparation for delivering a shock. Pressing the shockbutton 424 then delivers a defibrillation shock from the HV deliverycircuit 508 to the patient through the electrodes 416. As will bedescribed in more detail below, the controller can be configured toimplement a combined defibrillation and CPR pause mode of operation.

The controller 506 is coupled to further receive input from a microphone512 to produce a voice strip. The analog audio signal from themicrophone 512 is preferably digitized to produce a stream of digitizedaudio samples which may be stored as part of an event summary 530 in amemory 518. A user interface 514 may consist of the display 522, anaudio speaker (not shown), and front panel buttons such as the on-offbutton 518 and shock button 524 for providing user control as well asvisual and audible prompts. A clock 516 provides real-time clock data tothe controller 506 for time-stamping information contained in the eventsummary 530. The memory 518, implemented either as on-board RAM, aremovable memory card, or a combination of different memorytechnologies, operates to store the event summary 530 digitally as it iscompiled during the treatment of the patient. The event summary 530 mayinclude the streams of digitized ECG, audio samples, and other eventdata, as previously described. The event summary generally can be portedto another analysis or workstation or defibrillator either by wire orwireless transmission or by removing portable digital media which storesthe event summary for transfer to another device.

In accordance with the principles of the present invention the ECG frontend 502 is also configured to transmit a low level signal, under controlof the controller 506, to measure patient impedance. As is known,patient impedance can be measured during shock delivery by monitoringthe voltage and/or current of the shock pulse. At other times thepatient impedance can be measured by injecting a low level signal intothe patient from one electrode 416, receiving the response thereto onthe other electrode, and measuring the detected response to determinepatient impedance. In the example of a protocol of the present inventiondescribed below, the low signal injection technique is employed for thepurpose of detecting CPR chest compressions. The force of a chestcompression sharply changes the physiological path traveled by thesignal, causing a detectable change in the received signal. Hence, smallsignals can be injected continuously with periodic significant changesin the response being identified as due to chest compressions. The lowlevel response signals received by the ECG front end 502 are processedby the controller 506 with the changes being noted as chest compressionswhich affect the ECG and make the ECG signal unreliable for arrhythmiaanalysis at that time.

Another technique for detecting the occurrence of chest compressionsdisruptive to the ECG signal is to use the signals produced by a “smart”CPR puck. A CPR puck is a pad-like device which is placed on the chestof the patient and against which the chest compressions are applied. A“smart” CPR puck contains a sensor such as a force transducer oraccelerometer which produces a signal each time the CPR puck receivesthe force of a chest compression. See U.S. Pat. No. 6,306,107 (Myklebustet al.) which describes a device which uses a pressure pad as a CPR puckcontaining an accelerometer and a force activated switch to determinethe depth of depressions. One or more of these signals can be used in animplementation of the present invention to detect the occurrence of CPRchest compressions.

An AED with a mode of operation including a “CPR pause” period isillustrated in FIG. 4. Since studies have shown that early CPR can playa critical role in patient recovery, this mode is becoming increasinglypopular as an AED resuscitation protocol. Following attachment of theelectrodes to the patient, the AED analyzes the patient's cardiac rhythmat step 202. During the analysis, the AED is precharged in preparationfor delivery of electrotherapy. Based on the analysis, a determinationis made at step 204 whether to advise the delivery of electrotherapy. Ifthe analysis reveals a “shockable rhythm” in the patient's cardiacrhythm, delivery of electrotherapy is advised and at step 206 the AED isfully charged and a defibrillation pulse is delivered to resuscitate thepatient in response to the user pressing the shock button on the AED.This sequence can be repeated two additional times if the patient hasnot been resuscitated and a shockable rhythm is detected, resulting in atotal delivery of three shocks. Another protocol is a “single shock”protocol as described in U.S. patent application No. 60/751,268 (Snyder)filed Dec. 16, 2005. At the end of the shock sequence 208 or when ashock is not advised at 204, the AED enters a CPR pause period at 212.As CPR is performed by the rescuer, audio and/or visual prompts are usedto instruct the rescuer on the proper administration of CPR. Asynchronous tone may be produced by the AED to guide the rescuer in theproper rate of chest compressions. Typically, the CPR pause period is onthe order of one minute or more. Toward the end of the CPR pause periodthe AED is precharged in preparation for a possible post-CPR shockdelivery. At the conclusion of the CPR pause period the ECG is againanalyzed for a shockable rhythm at 214 and if none is detected, theprecharge is disarmed at 216 and the process returns to the initialrhythm analysis step 202. If a shockable rhythm is detected in thisstep, the protocol continues to advise a shock at 204 and deliver theshock at 206.

FIG. 5 illustrates a defibrillator operating protocol which includes aninterruptible CPR period in accordance with the principles of thepresent invention. At step 20 the AED acquires the patient's ECG signaland analyzes the ECG data to produce a likelihood of return ofspontaneous circulation (ROSC) score. The ROSC score is compared to athreshold to advise a treatment protocol which is more likely to besuccessful. See PCT application number IB2006/051897 (Snyder et al.),filed Jun. 13, 2006 which describes this technique, known commerciallyas “V-rhythm”, as used in Philips Medical Systems defibrillators. Thetreatment protocol can be to shock the patient first, then perform CPR.Another possible treatment protocol is to provide CPR to the patientbefore delivering a shock. In the example of FIG. 5 the step 24 selectseither a “shock first” protocol or a “CPR first” protocol.

The “shock first” protocol begins by performing ECG analysis at step 30.If a shock is advised at 32 as a result of the analysis, the AED chargesfor a shock at 34, arms the AED for shock delivery at 36, and promptsthe rescuer to deliver the shock at 38. Following shock delivery the AEDgoes into a CPR period at 40.

In the “CPR first” protocol the AED begins by first prompting therescuer to perform CPR on the patient at 40. In parallel the controller506 monitors the patient impedance signal or “smart” CPR puck signal andlooks for intervals during which an artifact-free ECG signal can bereceived. An ECG acquisition interval as short as four seconds can besufficient to enable a quick analysis of the ECG data to determine if ashockable rhythm is present. However, CPR is generally delivered at arate of about one hundred compressions per minute and CPR administrationat this rate will thwart attempt to acquire a clean ECG signal for fourseconds. But if the rescuer is interrupted or pauses to rest for a fewseconds or interrupts chest compressions to ventilate the patient, e.g.,by mouth-to-mouth resuscitation, this interval will be evidenced by acontinuously stable patient impedance and/or lack of compression signalsfrom the CPR puck, and an ECG signal of sufficient duration may becaptured for a quick ECG analysis at 44.

However, if the administration of CPR is rapid and continuous, therewill be no occurrence of a successful quick ECG analysis at 46 and,after a predetermined period of CPR administration such as a fullminute, the rescuer is prompted to pause in the administration of CPRcompressions at 42. With the CPR compressions interrupted at 42, asevidenced by the patient impedance or “smart” puck signal, a clean ECGsignal can be acquired for the necessary duration and analyzed at 44.When the necessary ECG signal has been acquired or the quick ECGanalysis is successful at 46, the rescuer is prompted at 48 to completethe administration of CPR and the AED is in its CPR pause mode until theCPR period is complete. Alternatively, if the analysis of the ECG dataindicates that a shock is advised, the protocol can terminate anyfurther CPR and proceed immediately to shock delivery 34, 36, 38. Towardthe end of the CPR period in the protocol of FIG. 5, the HV deliverycircuit 308 can be precharged as described in the aforementioned U.S.Pat. No. 6,553,257 (Snyder et al.) and US patent application publicationno. 2006/0116724 (Snyder).

At the conclusion of the CPR period, based on the result of the quickECG analysis, a shockable rhythm may have been identified and a shock isthen advised at 50. The AED is armed at 36 and the shock delivered at38. A variation of this is indicated by the dashed line between step 48and step 44, which is to perform another ECG acquisition and quick ECGanalysis at the end of the CPR period to verify that a shockable rhythmis still present before advising a shock sequence. But if a shock is notadvised, the AED will return to the CPR pause mode for theadministration of more CPR. Alternatively, in other protocols, the AEDmay enter a monitoring mode in which further monitoring and analysis ofthe ECG data is performed.

It may be seen from the foregoing that the identification of a shockablerhythm can be determined with only a short interruption to CPR. Sincechest compressions are not applied during the interruption, the ECG dataacquired is not contaminated by compression artifacts and is reliablefor arrhythmia analysis. As a result, an advice to shock can be givenimmediately after the patient has received the benefit of a full periodof CPR.

Variations to the protocol of FIG. 5 will readily occur to those skilledin the art. One variation of the protocol is to perform a V-rhythmanalysis 52 of the ECG data used for the quick ECG analysis to determinewhether a successful resuscitation is indicated. If the quick ECGanalysis indicates that a shock is advised and the V-rhythm analysisindicates that electrotherapy is likely to be successful, the CPR periodis interrupted at 54. While the rescuer is being prompted to cease CPRthe HV delivery circuitry is precharged so that the AED can be quicklyarmed and a shock delivered. In instances where a high likelihood of asuccessful resuscitation is determined, this variation is likely toprovide treatment best suited to the patient.

What is claimed is:
 1. A method for using a defibrillator to provideresuscitation therapy to a patient, comprising: obtaining anelectrocardiogram (ECG) signal via defibrillation electrodes; promptinga rescuer with the defibrillator to commence a cardio-pulmonaryresuscitation (CPR) period in which the defibrillator prompts to performCPR; monitoring the CPR period for the occurrence of an interval of apredetermined duration during which an ECG signal uncontaminated bycompression artifact may be acquired; if the predetermined durationoccurs, acquiring ECG data from the ECG signal that was obtained duringthe interval; if the predetermined duration does not occur, issuing avisual or audible prompt for interrupting the CPR period, and acquiringECG data from the ECG signal that is obtained during the interruption;and resuming the CPR period.
 2. The method of claim 1 furthercomprising: analyzing the acquired ECG data for a shockable rhythm. 3.The method of claim 2, further comprising: terminating further CPR anddelivering electrotherapy from a high-voltage energy source if ashockable rhythm is indicated.
 4. The method of claim 2, furthercomprising delivering electrotherapy at the conclusion of the resumedCPR period if the analyzing step indicates a shockable rhythm.
 5. Themethod of claim 1, wherein the monitoring step further comprises:monitoring for CPR compressions during the CPR period.
 6. The method ofclaim 5, wherein monitoring for CPR compressions further comprises:monitoring a patient impedance.
 7. The method of claim 6, whereinmonitoring the patient impedance further comprises applying a low levelsignal by means of an electrode and monitoring a response thereto. 8.The method of claim 7, wherein monitoring for CPR compressions furthercomprises: monitoring a signal produced in response to a sensed force ofa chest compression.
 9. A method for using a defibrillator to provideresuscitation therapy to a patient, comprising: obtaining anelectrocardiogram (ECG) signal via defibrillation electrodes; promptinga rescuer with the defibrillator to commence a CPR period during whichCPR chest compressions may be applied to the patient; monitoring duringthe CPR period for an interval when ECG signals can be acquired withoutcontamination by chest compression artifacts; prior to the end of theCPR period, if no such interval has occurred, prompting the rescuer tointerrupt the CPR chest compressions; and acquiring ECG signals whichare not contaminated by chest compression artifacts during either of theinterval and the prompted interruption.
 10. The method of claim 9,further comprising: performing an analysis of acquired ECG signals for ashockable rhythm.
 11. The method of claim 10, further comprising: priorto the termination of the resumed CPR period, precharging thedefibrillator; and following the termination of the CPR period,delivering a defibrillation shock sequence to the patient if theanalysis of acquired ECG signal has indicated a shockable rhythm. 12.The method of claim 10, further comprising: if the analysis of acquiredECG signals has indicated a shockable rhythm, analyzing the ECG signaldata to estimate the likelihood of a successful resuscitation; and if asuccessful resuscitation is likely, terminating any ongoing CPR for thedelivery of a defibrillation shock sequence to the patient.
 13. Themethod of claim 9, wherein monitoring during the CPR period furthercomprises monitoring for chest compressions by one of monitoring patientimpedance or monitoring for signals produced in response to a force of achest compression.